18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUBEScan BioCon-900 (Bladder Volume Measurement System)
FDA 510(k)
FDA Class 2
·Radiology
SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077972·Deaver retractor,serr. working end
25 x 3...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077927·Deaver Retractor
19 x 1...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077941·DEAVER retractor 25x230 mm
9", wi...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077934·DEAVER retractor 22x215 mm
serrat...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077965·DEAVER retractor 25x330 mm
serrat...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077958·DEAVER retractor 25x300 mm
serrat...
RAMP INFLUENZA A/B ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
STINGRAY ORIENTING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KNW·March 12, 2026
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·October 14, 2014
PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·June 15, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 21, 2011
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·October 8, 2025
SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021